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CDRH Launches ‘Innovation Pathway 2.0’ With End-Stage Renal Devices

This article was originally published in Start Up

Executive Summary

Participants expect the program to tangibly reduce time to market and improve companies’ prospects for raising money.

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FDA-Selected Kidney Disease Devices Still In Early Development

Investigational devices from CreatiVasc Medical, Blood Purification Technologies and the University of California, San Francisco were selected for CDRH’s “innovation pathway 2.0” program.

FDA’s Final Risk-Benefit Guidance Excludes 510(k)s, Adds De Novo Petitions

Device center reviewers will begin applying the guidance to incoming PMA and de novo submissions and to submissions already under review with decisions beginning on May 1.

Next Step On the Innovation Pathway: Renal Disease Devices

FDA issued an “innovation challenge” Jan. 12 asking companies developing devices for end-stage renal disease to volunteer for a pilot program designed to assess new statistical tools and collaborative processes that the agency hopes will accelerate product development.

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